Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc
09/16/21 • 38 min
When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.
Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.
Some of the highlights of this episode include:
- What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.
- Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.
- Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.
- Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.
- UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.
- Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.
- Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.
Memorable quotes from this episode:
“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues
“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues
“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer
“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike Drues
Links:
FDA UDI Homepage: Unique Device Identification System
FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)
Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers
Code of Federal Regulations (CFR)
FDA - 510(k) Submission Process
FDA - Software as a Medical Device (SaMD)
FDA - Premarket Approval (PMA)
...
When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.
Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.
Some of the highlights of this episode include:
- What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.
- Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.
- Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.
- Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.
- UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.
- Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.
- Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.
Memorable quotes from this episode:
“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues
“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues
“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer
“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike Drues
Links:
FDA UDI Homepage: Unique Device Identification System
FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)
Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers
Code of Federal Regulations (CFR)
FDA - 510(k) Submission Process
FDA - Software as a Medical Device (SaMD)
FDA - Premarket Approval (PMA)
...
Previous Episode
Addressing the 'Who, What, When' of Quality in the Medical Device Industry
There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.
In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry.
Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.
Some of the highlights of this episode include:
- Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.
- What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.
- Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.
- Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.
- Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.
- Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.
- What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.
- Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.
Memorable quotes from Christie Johnson:
“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”
“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”
“The system that you should implement is the one that your team will use and make it easy.”
“It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”
Links:
National Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
Next Episode
Past, Present, Future State (and World) of Quality in the Medical Device Industry
Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!
In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.
Some of the highlights of this episode include:
- Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.
- It takes time, often several years, for companies to transition to new or revised regulations and standards.
- Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.
- Some medical device companies have lost their way when it comes to quality, and many believe the quality profession is partly to blame for being driven by tools, not data.
- Mark describes a do versus don’t do mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.
- Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.
Memorable quotes from this episode:
“I think today, we’re also at a very interesting crossroads when it comes to quality. There’s a number of different facets.” Jon Speer
“It’s going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert
“Once complexity creeps into the system, you’re just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert
“A lot of companies, I think their quest is towards compliance.” Jon Speer
Links:
FDA - Quality System Regulation
European Union Medical Device Regulation (EU MDR)
European Union In Vitro Diagnostics Regulation (EU IVDR)
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
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